In March 2012, Granuflo, manufactured by Fresenius Medical Care, was subject to a Class I recall. This is the most serious recall possible, and is often used when there is reasonable probability that a drug will cause serious health problems or death. The affected drugs were Naturalyte Liquid Acid concentrate and the Naturalyte GranuFlo powder acid concentrate, both used during hemodialysis to treat acute or chronic kidney failure. One of the main ingredients in these drugs is converted by the body into bicarbonate, an alkaline substance also prescribed separately during dialysis, to help neutralize acid in the patients’ blood. It has been reported, however, that Naturalyte and GranuFlo contain a higher amount of this ingredient than similar medications, which has led to overprescribing by some medical professionals. An overdose of bicarbonate has been linked to irregular heartbeat, low blood pressure, low potassium levels, and low oxygen blood pressure. These conditions, if not identified and treated properly, may cause cardiopulmonary arrest and even death.
The FDA is attempting to determine whether Fresenius violated federal laws by failing to alert doctors and patients to the risks associated with the drugs. It has been reported that the company knew about the drugs’ cardiac arrest risk, but failed to alert the FDA in a timely manner. Instead, an internal memo was released, which was subsequently leaked to the agency, according to reports.
In March 2013, federally-filed Granuflo lawsuits were consolidated, allowing a speedier and more effective handling of the cases. More than 180 lawsuits are pending and allege that the drug poses a serious risk of cardiac arrest in some patients. According to the suits, the company failed to properly warn doctors and medical professionals about complications associated with the use of GranuFlo, and this lack of proper medical information was a contributing factor in some patients’ health problems.
The attorneys working with ClassAction.org are offering free case reviews to any former GranuFlo or Naturalyte patients who have experienced cardiac arrest during or following their treatment. For more information and to receive this no obligation review, please visit ClassAction.org today.
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Class Action.org is dedicated to protecting consumers and investors in class actions and complex litigation throughout the United States. Class Action.org keeps consumers informed about product alerts, recalls, and emerging litigation and helps them take action against the manufacturers of defective products, drugs, and medical devices. Information about consumer fraud issues and environmental hazards is also available on the site. Visit http://www.classaction.org today for a no cost, no obligation case evaluation and information about your consumer rights.
Accidents.com
Whitney Shields
8004491970
pressrelease@lawyercentral.com
Source: EmailWire.Com
